–It’s still not time to write the obituary for all HDL therapies. There was good news and bad news for a category of experimental drugs that attempt to mimic the putative beneficial effect of HDL at the American Heart Association meeting in New Orleans. Thirteen years after setting the field on fire with a promising…
Strike 2 For Once Promising GSK ‘Stinkbomb’ Heart Drug
May 13, 2014 by Leave a Comment
GSK said today that a large phase 3 trial of a once highly-promising drug had failed to meet its primary endpoint. Last year the company announced that another phase 3 trial with the same drug had failed. GSK said it would “further analyse the data and better understand the findings” but that, for now at least, it…
FDA Once Again Rejects New Indication For Rivaroxaban
February 14, 2014 by Leave a Comment
The third time wasn’t the charm. The FDA today turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in…
Younger Women With Acute Coronary Syndromes Less Likely To Have Classic Chest Pain
September 17, 2013 by Leave a Comment
Younger women with an acute coronary syndrome are slightly less likely than men to present with the classic symptom of chest pain, according to a new study published in JAMA Internal Medicine. In recent years there has been a growing understanding that women with ACS are less likely to have chest pain and, partly as a result,…
New Test Could Speed Heart Attack Treatment In The Emergency Department
September 4, 2013 by Leave a Comment
Only 1 in 10 patients with acute chest pain in the emergency department turn out to have an actual heart attack (myocardial infarction), yet many are not released from the hospital until after 6-12 hours of cardiac monitoring and multiple ECG and troponin tests. The search for a test that can rule out MI early in…
FDA Turns Back New Indication For Rivaroxaban To Prevent Stent Thrombosis In ACS Patients
June 28, 2013 by Leave a Comment
Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application for rivaroxaban (Xarrelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the general use of rivaroxaban to…
FDA Again Rejects ACS Indication for Rivaroxaban (Xarelto)
March 4, 2013 by Leave a Comment
For the second time the FDA has turned down the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) to treat patients with acute coronary syndrome (ACS). … In a new press release issues on Monday afternoon, the company restated its confidence “in the robustness and results of the ATLAS…
Expert Consensus Document Offers Advice On Troponin Tests
November 13, 2012 by Leave a Comment
A newly published document provides practical advice on the use of the popular and potent troponin tests. The Expert Consensus Document on Practical Clinical Considerations in the Interpretation of Troponin Elevations was developed by the American College of Cardiology Foundation in collaboration with several other societies to help address the many complex issues raised by the introduction…
TRILOGY At ESC: No Advantage For Prasugrel Over Clopidogrel In Medical ACS Patients
August 26, 2012 by Leave a Comment
The newer antiplatelet agent prasugrel was no better than the old standby clopidogrel for treating patients with acute coronary syndrome (ACS) who are not undergoing revascularization. The results of the TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) trial were presented by Matt Roe at the European Society of…
FDA Rejects ACS Indication for Rivaroxaban (Xarelto)
June 21, 2012 by 2 Comments
The FDA has issued a complete response letter to the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) in patients with acute coronary syndrome (ACS). The action was expected, since last month the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against recommending the new indication, which was based on…
FDA Advisory Committee Recommends Against ACS Indication For Rivaroxaban
May 23, 2012 by 1 Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against adding an indication for acute coronary syndromes (ACS) to the label of the anticoagulant rivaroxaban (Xarelto). The vote was 6 to 4 against approval, with 1 abstention. The advisory panel spent most of the day trying to reconcile diametrically opposed views of the pivotal ATLAS ACS 2-TIMI…
Live Blog: The FDA Advisory Panel For Rixaroxaban for ACS
May 23, 2012 by 1 Comment
Here’s my live-blogg of the FDA’s Cardiovascular and Renal Drugs Advisory Committee meeting to consider the supplemental new drug application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. Here is a link to the FDA briefing documents. ========================= 4:48: Meeting adjourned! J&J has just issued a press release…
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